Comparing the effectiveness of saline irrigation and Bactisure® solution in debridement surgery for acute periprosthetic joint infections

Efficacy of the preformulated irrigation solution Bactisure® in acute periprosthetic joint infection debridement surgery: a randomized controlled trial

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN10873696

Enrollment

Registered

2023-12-19

Start date

2022-12-01

Completion date

Unknown

Last updated

2025-01-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Patients diagnosed with acute or hematogenous periprosthetic hip or knee infection (PJI) eligible for debridement, antibiotic and implant retention (DAIR) surgery Surgery

Interventions

This single-center randomized controlled trial comprises two groups allocated in a 1:1 ratio. To achieve balanced patient distribution, a restrictive randomization method will be employed, which entai

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Age >18 years old 2. Patients with hip or knee prostheses 3. Diagnosis of periprosthetic joint infection according to the criteria established in the Second International Consensus on Musculoskeletal Infections 4. Acute PJI: <6 weeks since the initial arthroplasty surgery 5. Acute hematogenous PJI: <3 weeks from symptom onset, documented bacteremia (positive blood culture) with the same microorganism in joint fluid 6. No previous debridement surgeries 7. Surgery performed: DAIR

Exclusion criteria

Exclusion criteria: 1. Patients who do not voluntarily and without coercion agree to participate in this clinical trial 2. Patients under 18 years of age 3. Prosthetic reinfections or a history of multiple debridements 4. Known sensitivity or allergic reaction to ethanol, acetic acid, sodium acetate, or benzalkonium chloride 5. Diagnosis of Chronic PJI: the presence of fistula or >6 weeks 6. Multiple infected implants (>1) 7. Medically unfit for DAIR surgery 8. Pregnancy 9. Legal incapacity

Design outcomes

Primary

Measure	Time frame
Current primary outcome measure as if 22/07/2024: Infection cure rate measured using the following criteria at the 12-month follow-up: A case will be considered cured if it meets all of the following requirements: 1. Absence of local recurrence, indicated by the absence of dehiscence, exudation, or fistula 2. Radiographic evidence of no osteolysis 3. No ongoing suppressive antibiotic treatment 4. Absence of any re-interventions 5. No deaths related to periprosthetic infection _____ Previous primary outcome measure as of 07/02/2024: Infection cure rate measured using the following criteria at the 6-month follow-up: A case will be considered cured if it meets all of the following requirements: 1. Absence of local recurrence, indicated by the absence of dehiscence, exudation, or fistula 2. Radiographic evidence of no osteolysis 3. No ongoing suppressive antibiotic treatment 4. Absence of any re-interventions 5. No deaths related to periprosthetic infection _____ Previous primary outcome measure: Infection cure rate measured using the following criteria at the 12-month follow-up: A case will be considered cured if it meets all of the following requirements: 1. Absence of local recurrence, indicated by the absence of dehiscence, exudation, or fistula 2. Radiographic evidence of no osteolysis 3. No ongoing suppressive antibiotic treatment 4. Absence of any re-interventions 5. No deaths related to periprosthetic infection	—

Measure

Time frame

Current primary outcome measure as if 22/07/2024: Infection cure rate measured using the following criteria at the 12-month follow-up: A case will be considered cured if it meets all of the following requirements: 1. Absence of local recurrence, indicated by the absence of dehiscence, exudation, or fistula 2. Radiographic evidence of no osteolysis 3. No ongoing suppressive antibiotic treatment 4. Absence of any re-interventions 5. No deaths related to periprosthetic infection _____ Previous primary outcome measure as of 07/02/2024: Infection cure rate measured using the following criteria at the 6-month follow-up: A case will be considered cured if it meets all of the following requirements: 1. Absence of local recurrence, indicated by the absence of dehiscence, exudation, or fistula 2. Radiographic evidence of no osteolysis 3. No ongoing suppressive antibiotic treatment 4. Absence of any re-interventions 5. No deaths related to periprosthetic infection _____ Previous primary outcome measure: Infection cure rate measured using the following criteria at the 12-month follow-up: A case will be considered cured if it meets all of the following requirements: 1. Absence of local recurrence, indicated by the absence of dehiscence, exudation, or fistula 2. Radiographic evidence of no osteolysis 3. No ongoing suppressive antibiotic treatment 4. Absence of any re-interventions 5. No deaths related to periprosthetic infection

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Secondary

Measure	Time frame
Current secondary outcome measures as of 22/07/2024: 1. Length of hospital stay, in days, measured using medical records at one timepoint 2. Potential postoperative complications (e.g. infections, re-operations, osteolysis) at hospitalization or in ambulatory controls measured using medical records at one timepoint 3. Microorganism identified on perioperative cultures, at hospitalization measured using standard laboratory methods at one timepoint 4. Pain level measured using the Visual Analogue Scale (VAS) Pain Score at 2, 6 and 12 months postoperatively 5. Patient functionality status measured using the Harris Hip Score (HHS) or Oxford Knee Score (OHS) at 6 months and 12 months post-surgery _____ Previous secondary outcome measures as of 07/02/2024: 1. Length of hospital stay, in days, measured using medical records at one timepoint 2. Potential postoperative complications (e.g. infections, re-operations, osteolysis) at hospitalization or in ambulatory controls measured using medical records at one timepoint 3. Microorganism identified on perioperative cultures, at hospitalization measured using standard laboratory methods at one timepoint 4. Pain level measured using the Visual Analogue Scale (VAS) Pain Score at 2, 4 and 6 months postoperatively 5. Patient functionality status measured using the Harris Hip Score (HHS) or Oxford Knee Score (OHS) at 4 months and 6 months post-surgery _____ Previous secondary outcome measures: 1. Length of hospital stay, in days, measured using medical records at one timepoint 2. Potential postoperative complications (e.g. infections, re-operations, osteolysis) at hospitalization or in ambulatory controls measured using medical records at one timepoint 3. Microorganism identified on perioperative cultures, at hospitalization measured using standard laboratory methods at one timepoint 4. Pain level measured using the Visual Analogue Scale (VAS) Pain Score at 2, 6 and 12 months postoperatively 5. Patient functionality status	—

Measure

Time frame

Current secondary outcome measures as of 22/07/2024: 1. Length of hospital stay, in days, measured using medical records at one timepoint 2. Potential postoperative complications (e.g. infections, re-operations, osteolysis) at hospitalization or in ambulatory controls measured using medical records at one timepoint 3. Microorganism identified on perioperative cultures, at hospitalization measured using standard laboratory methods at one timepoint 4. Pain level measured using the Visual Analogue Scale (VAS) Pain Score at 2, 6 and 12 months postoperatively 5. Patient functionality status measured using the Harris Hip Score (HHS) or Oxford Knee Score (OHS) at 6 months and 12 months post-surgery _____ Previous secondary outcome measures as of 07/02/2024: 1. Length of hospital stay, in days, measured using medical records at one timepoint 2. Potential postoperative complications (e.g. infections, re-operations, osteolysis) at hospitalization or in ambulatory controls measured using medical records at one timepoint 3. Microorganism identified on perioperative cultures, at hospitalization measured using standard laboratory methods at one timepoint 4. Pain level measured using the Visual Analogue Scale (VAS) Pain Score at 2, 4 and 6 months postoperatively 5. Patient functionality status measured using the Harris Hip Score (HHS) or Oxford Knee Score (OHS) at 4 months and 6 months post-surgery _____ Previous secondary outcome measures: 1. Length of hospital stay, in days, measured using medical records at one timepoint 2. Potential postoperative complications (e.g. infections, re-operations, osteolysis) at hospitalization or in ambulatory controls measured using medical records at one timepoint 3. Microorganism identified on perioperative cultures, at hospitalization measured using standard laboratory methods at one timepoint 4. Pain level measured using the Visual Analogue Scale (VAS) Pain Score at 2, 6 and 12 months postoperatively 5. Patient functionality status

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Countries

Spain

Contacts

Public ContactRafael Oleo

rafael.oleo@vallhebron.cat+34 934 893 480

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 6, 2026